NCT04186377

Application of S26E for Diabetic Foot Ulcer Healing

A Study of the Effectiveness of Local S26E Extract Application for Diabetic Foot Ulcer Healing

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: National and Kapodistrian University of Athens · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A randomized, controlled open-label, parallel group study to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil for the healing of non-infected diabetic foot ulcers.

Detailed description

This is a randomized, controlled open-label, parallel group study of 12 weeks duration aimed to examine the effectiveness of a local application of the kalahari melon (Citrullus lanatus) seed oil (S26E) for the healing of non-infected chronic (\>12 weeks) diabetic foot ulcers. The S26E is a natural extract rich in unsaturated (such as linoleic, oleic, palmitic and static) fatty acids which have shown promise in the promotion of wound healing by modulating the migration and functional properties of inflammatory cells in wound cites as well as the production of inflammatory cytokines. The safety of topical S26E application on human skin has been clinically demonstrated. Eligible participants will be adults patients with diabetes mellitus (DM) type 1 or 2 and chronic (persistent for \>12 weeks after initial presentation) neuropathic or neuroischaemic non-infected diabetic foot ulcers. Following recruitment and randomization (on a 1:1 ratio) eligible patients will attend the study site on weekly intervals. After a run-in period of 2 weeks (visits 1-2) during which all participants will receive the optimal standard-of-care for neuropathic/neuroischaemic diabetic ulcers (incl. optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing) eligibility will be reassessed. Participants who will continue in the study will receive standard of care (control group) or standard of care plus daily local S26E application on ulcer (intervention group) (visits 3-12). After visit 12 the application of S26E will be terminated and all participants will receive an additional follow up visit 4 weeks later (final visit). Efficacy end-points will be assessed at the end of the of 12 weeks of observation (Visit 12)

Conditions

• Diabetic Foot
• Neuropathic Foot Ulcer
• Chronic Diabetic Ulcer of Left Foot (Diagnosis)
• Chronic Diabetic Foot Ulcer of Right Foot

Interventions

Type	Name	Description
OTHER	Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers	Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing
DRUG	S26E	Daily application of S26E extract on wound site

Timeline

• Start date: 2020-05-15
• Primary completion: 2021-11-29
• Completion: 2021-11-29
• First posted: 2019-12-04
• Last updated: 2022-06-08

Locations

1 site across 1 country: Greece